Coronary Artery Disease
Conditions
Keywords
ABT -CIP 10445, Coronary artery disease, XIENCE, Large Vessel, Skypoint
Brief summary
SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.
Interventions
DEVICEXIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)
XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent per site requirements. 3. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following: 1. Abnormal stress or imaging stress test 2. Abnormal computed tomography-fractional flow reserve (CT-FFR) 3. Stenosis by visual estimation ≥ 70% 4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\]) 4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria 1. Patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion 2. Patients who receive at least one Skypoint LV stent 1. Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents 2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Primary Endpoint: Target Lesion Failure (TLF) | At 1 Year | TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI) | 1 year | TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR. |
Countries
France, Spain, United States
Participant flow
Recruitment details
The study registered a total of 102 subjects at 18 investigational sites on September 14, 2022 to November 8, 2023. and all active subjects enrolled completed their 12-month follow-up.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Hyperlipidemia | 76 Participants |
| Hypertension | 81 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 69 Participants |
| Race/Ethnicity, Customized Declined or unable to disclose due to local regulation | 25 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 79 Participants |
| Tobacco use | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 102 |
| other Total, other adverse events | 80 / 102 |
| serious Total, serious adverse events | 35 / 102 |
Outcome results
None listed